NAVISTAR® THERMOCOOL® Catheter Post Approval Registry (AF Registry)

This study is ongoing, but not recruiting participants.

Sponsor:

Biosense Webster, Inc.

ClinicalTrials.gov Identifier:

NCT00964392

First Posted: August 24, 2009

Last Update Posted: September 20, 2017

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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The purpose of this registry is to provide additional corroborative short-term safety and long-term safety data for the NAVISTAR THERMOCOOL and NAVISTAR EZ STEER THERMOCOOL catheters in the treatment of symptomatic Paroxysmal Atrial Fibrillation (PAF).

Percentage of Subjects Experienced Serious Adverse Events. [ Time Frame: First study day to 5 year post-ablation ]

The occurrence of serious adverse events (SAE) was used to provide the prospective long-term safety data. The SAEs are summarized by the following time periods: 0 to 30 days post-ablation, 31 days to 365 post-ablation, 366 to 730 days post-ablation, and more than 730 days post-ablation. One subject might have experienced SAEs in more than one time periods. This report covers the SAEs occurred from September 29, 2009 (first patient enrolled) to June 23, 2015 (data download date for this report).

Physicians who perform greater than or equal to 50 atrial fibrillation ablation procedures per year.

Procedure: Atrial fibrillation ablation

Radiofrequency ablation

Experimental: Less-Experienced Physicians (LEP)

Physicians who perform less than 50 atrial fibrillation ablation procedures per year.

Procedure: Atrial fibrillation ablation

Radiofrequency ablation

Detailed Description:

This registry is a prospective, multi-center, non-randomized post approval evaluation comprised of two (2) registry arms with independent hypotheses. The registry arms are defined as; Arm 1) physicians who perform greater than or equal to 50 atrial fibrillation ablation procedures per year and Arm 2) physicians who perform less than 50 atrial fibrillation ablation procedures per year. Subjects with drug refractory recurrent symptomatic PAF will be considered for this post approval registry. This registry will be conducted at up to 40 centers in a minimum of 381 evaluable subjects. The devices are currently FDA approved for commercial distribution under PMA #P030031/S11.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Candidates for this registry must meet ALL of the following criteria:

Patients with drug refractory recurrent symptomatic PAF who have had three (3) AF episodes in the six (6) months prior to enrollment and one AF episode documented within the one (1) year prior to enrollment. Documentation may include electrocardiogram (ECG), transtelephonic monitor (TTM), Holter monitor (HM), or telemetry strip.

Failure of at least one AAD for AF (class I or III or AV nodal blocking agent such as beta blockers and calcium channel blockers) as evidenced by recurrent symptomatic PAF, or intolerable side effects.

Age 18 years or older.

Able and willing to comply with all pre-, post- and follow-up testing and requirements.

Signed Patient Informed Consent Form.

Exclusion Criteria:

Candidates will be excluded from the registry if any of the following conditions apply: